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BIOGRAPHY

Andrew Cole

Manager, Tailored Solutions, BSI, Parrish, FL, USA

Andrew rejoined BSI in 2020 within Customized/Tailored Solutions. With over 25 years of Quality/Regulatory and solutions based compliance, he has extensive experience in GMP Manufacturing & Regulatory Requirements.

He possesses 7 years of developing complex global supply chain compliance solutions (2nd party audit schemes) pertaining, but not limited to, sustainability, CSR, EH&S, quality, legal, ethical, and regulatory. His expertise is also in the application of ISO 9001, ISO 13485, Canadian Medical Device Regulations, FDA 21CFR’s, European Directives for Medical Devices, Cosmetics and Pharmaceuticals, Medicinal and recreational Cannabis regulation, CE Marking, ISO 22716, ISO 13485, GDP, EFfCI, EXCiPACT, ISO 15378.

While working for multiple international companies, he has successfully completed major projects to Remediate/Eliminate Deficiencies/Gaps in management systems based on evidence gleaned from internal audits and externally assessed findings, i.e., 483’s, & Warning Letters.




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(*) based on previous conference attendance






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